CompletedNot Applicable

PRIMARY NEEDLE KNIFE FISTULOTOMY

Portugal400 participantsStarted 2021-01-01

Plain-language summary

Evaluate the outcomes of NKF as an initial method for biliary access.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ERCP with indication for biliary access * Naïve papilla Exclusion Criteria: * Patients unable to sign or understand the informed consent * Patients with surgically altered anatomy * Patients with tumors of the papilla * Previous sphincterotomy * Spontaneous papillary fistula * Papilla not visualized

What they're measuring

Adverse events

Timeframe: 30 days from the procedure

Technical success

Timeframe: 1 day (same day of the procedure)

Trial details

NCT IDNCT06452875

SponsorUniversity of Minho

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-31

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